MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV VFI PACK FOR SILICONE OIL SYRINGES

Catalog Number	1363.DD
Medical Device Problem Codes	Material Separation (1562); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.The investigation showed that the lot number of the 1363.Dd that was involved was part of the recalled of last year.Dorc was informed that the stock was discarded, this reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with (b)(4) during a tele-conference on 05/31/2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Sil5000.S exploded in combination with 1363.Dd lot# sil5000.S: 34714.Information suggests no patient harm.

• Brand Name: VFI PACK FOR SILICONE OIL SYRINGES
• Common Device Name: VFI PACK FOR SILICONE OIL SYRINGES
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7566804
• Report Number: 1222074-2018-00169
• Device Sequence Number: 2527003
• Product Code: HQC
• UDI-Device Identifier: 08717872007199
• UDI-Public: 08717872007199
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 1363.DD
• Device Lot Number: 2000368036
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2016
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1